Cleared Special

K002967 - M2376A DEVICELINK SYSTEM

K002967 is the FDA 510(k) clearance for M2376A DEVICELINK SYSTEM by Agilent Technologies, Inc.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Special 510(k) pathway after a 26-day FDA review.

K002967 · Agilent Technologies, Inc. · Cardiovascular device
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Oct 2000
Decision
26d
Days
Class 2
Risk

K002967 is an FDA 510(k) clearance for the M2376A DEVICELINK SYSTEM, MODEL M2376A. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Agilent Technologies, Inc. devices

Submission Details

510(k) Number K002967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date October 18, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 150
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